Nature and Scope
This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. They ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate, and that safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other departments as needed, playing a critical role in maintaining production schedules and meeting company goals. The Team Member will be able to participate in all aspects of the Compounding Process. The Compounding Process includes: dispensing of raw material, controlling and utilizing chemical raw materials in accordance with batch directions; performing in-process QC sampling and on-site in process testing of pH, oxygen content, clarity, etc. during batch formulation; sterile dispensing of raw material (Hilliard Facility), compounding, sterile compounding (Hilliard Facility), sterile filtration, cleaning, assembling, and sterilizing small and large pieces of equipment, and the tear-down and line clearances of the manufacturing equipment. The Compounding Process will be performed in accordance with established production records and company SOPs in a concerted effort to manufacture sterile liquid pharmaceuticals. The Team Member will assist in all activities associated with the compounding process under the direct supervision of Senior Manufacturing Team Members.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Utilizes scales, balances, and load cells to weigh materials and perform batch additions of materials.
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Performs aseptic filtration setup and filter integrity testing.
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Utilizes blending, mixing and other homogenization technologies.
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Performs mass/concentration calculations to determine batch dosing in accordance with material potency.
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Stocks, gathers, and stages manufacturing supplies and equipment as needed.
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Gathers, stages, and returns production materials as needed to support manufacturing activities.
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Cleans and stores manufacturing equipment and cleans areas as needed to support manufacturing activities.
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Understanding of basic process analytical methods (i.e., pH measurements and adjustments, dissolved oxygen content, etc.)
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Attends all training programs as required by Company SOPs, procedures, and policies.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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High School Diploma or GED equivalent required. Associate degree in chemistry or other science field is a plus.
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1-3 years related field work experience is preferred.
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Experience with manufacturing technology such as HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization preferred.
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Ability to work in an environment where chemicals are handled and dispensed daily.
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Excellent chemical handling and mathematical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.
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Ability to meet and maintain Class 100 Certification for sterile compounding/transfer (Hilliard facility) as well as maintain cleanroom gowning and respirator fit testing requirements.
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Able to take feedback constructively and function in a team-oriented work environment.
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
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Ability to work overtime as needed.
Physical Environment and Requirements
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Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
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Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
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Employee must be able to occasionally lift and/or move up to 50 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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